Browse Drug Recalls
1,152 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,152 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 1,152 FDA drug recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 27, 2021 | CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine, ... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 cou... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 26, 2021 | Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bott... | Marketed Without an Approved NDA/ANDA | Class II | High Performance Formulas, L.L.C. (HPF, L.L.C.) |
| Jul 23, 2021 | PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable Int... | SubPotent: Out of Specification | Class II | Professional Disposables International, Inc |
| Jul 23, 2021 | PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Profession... | SubPotent: Out of Specification | Class II | Professional Disposables International, Inc |
| Jul 23, 2021 | PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Pr... | SubPotent: Out of Specification | Class II | Professional Disposables International, Inc |
| Jul 23, 2021 | PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable In... | SubPotent: Out of Specification | Class II | Professional Disposables International, Inc |
| Jul 23, 2021 | PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable Inter... | SubPotent: Out of Specification | Class II | Professional Disposables International, Inc |
| Jul 23, 2021 | PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professiona... | SubPotent: Out of Specification | Class II | Professional Disposables International, Inc |
| Jul 23, 2021 | PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packag... | SubPotent: Out of Specification | Class II | Professional Disposables International, Inc |
| Jul 20, 2021 | Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : ... | Marketed without ANDA/NDA approval | Class II | HIS ENTERPRISE INC |
| Jul 19, 2021 | Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma... | Correct Labeled Product Mispack | Class II | Teligent Pharma, Inc. |
| Jul 19, 2021 | Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Red... | Failed Tablet/Capsule Specification: Some tablets are shaved | Class II | Dr. Reddy's Laboratories, Inc. |
| Jul 19, 2021 | Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent P... | Correct Labeled Product Mispack | Class II | Teligent Pharma, Inc. |
| Jul 16, 2021 | ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distrib... | Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil | Class I | Alpha-Tek LLC |
| Jul 15, 2021 | Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne ... | cGMP Deviations | Class II | API Solutions Inc. |
| Jul 15, 2021 | Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendsh... | cGMP Deviations | Class II | API Solutions Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | Chemical Contamination: presence of benzene | Class I | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzon... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 4... | Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine. | Class I | Qikmoov LLC |
| Jul 14, 2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60, Avobenzo... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | Chemical Contamination: presence of benzene | Class I | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45, Avobenzone ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70, Avobenzone... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone (3%), Homosalate ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRU... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 12, 2021 | QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, M... | Subpotent | Class II | NATIVE PROMOTIONS, INC |
| Jul 9, 2021 | Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injec... | Lack of Assurance of Sterility | Class II | Innoveix Pharmaceuticals Inc |
| Jul 9, 2021 | Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramus... | Lack of Assurance of Sterility | Class II | Innoveix Pharmaceuticals Inc |
| Jul 7, 2021 | Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 5... | Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the ... | Class III | LNK International, Inc. |
| Jul 7, 2021 | Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, ... | Presence of Foreign Substance- Potential of metal contamination. | Class II | Aurobindo Pharma USA Inc. |
| Jul 2, 2021 | NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 cou... | Failed Dissolution Specification: Out of specification for dissolution during routine stability t... | Class II | The Harvard Drug Group |
| Jul 2, 2021 | Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By... | Temperature abuse: the firm received customer complaints of unusual grittiness in the product. | Class I | KVK-Tech, Inc. |
| Jun 30, 2021 | Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-ste... | CGMP Deviations: Does not meet monograph for denaturant. | Class II | Cascade Kelly Holdings LLC |
| Jun 30, 2021 | Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-ste... | CGMP Deviations: Does not meet monograph for denaturant. | Class II | Cascade Kelly Holdings LLC |
| Jun 30, 2021 | MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50... | Lack of processing controls | Class II | Promise Pharmacy, LLC |
| Jun 29, 2021 | Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, R... | cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cak... | Class II | Eli Lilly & Company |
| Jun 25, 2021 | Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Inje... | Low out of specification results for epinephrine assay. | Class II | Fresenius Kabi USA LLC |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.